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EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.

EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.

The provided text is an FDA 510(k) summary for a medical device called the EMBOGUARD™ Balloon Guide Catheter (K233924). This document primarily focuses on establishing "substantial equivalence" of the new device to a previously cleared predicate device (K212340), rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance metrics for AI/software.

The context of your request seems to imply the device might be an AI or software-based product given your detailed prompts about MRMC studies, ground truth, and expert adjudication. However, this FDA submission is for a physical medical device (catheter) and not an AI or software device. Therefore, many of the specific questions you've asked (e.g., sample size for test/training sets for AI, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of device submission.

The "acceptance criteria" discussed in this document relate to bench testing, biocompatibility, and sterilization to demonstrate that the modified physical device performs as safely and effectively as its predicate.

Based on the provided text, here's what information is available and how it aligns (or doesn't align) with your request:

Device Type: Physical Medical Device (Balloon Guide Catheter), not an AI/software device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance tests with "Pass" results, indicating adherence to pre-determined acceptance criteria. However, quantitative acceptance criteria are generally not explicitly stated with specific numerical values in this summary, but rather implied by meeting internal specifications or relevant standards.

Here's a summary of the performance categories and their reported outcomes:

Note on Quantitative Data: For most bench tests, the summary states "All samples met the pre-determined acceptance criteria." without providing the specific numerical criteria or the actual measured values. For "Kink to Failure" and "Particulates", it's noted as "Characterization only" or "found comparable," indicating that precise numerical "pass/fail" limits might not have been applied as rigorously as for other tests, but rather assessed for equivalence to the predicate.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the summary for each individual test. The document mentions "All samples" for the bench tests, implying a sufficient number were tested per internal protocols and relevant standards. For biocompatibility, it refers to standard test methods where sample sizes are typically defined by those standards.
• Data Provenance: Not applicable in the context of patient data. The "data" here comes from laboratory bench testing and biological assays conducted according to established protocols and standards. The testing was conducted by or for Neuravi Ltd., based in Ireland.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This is a physical device, not an AI/software system requiring expert interpretation of medical images. Ground truth for its performance is established through physical measurements, chemical assays, and mechanical tests according to engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not Applicable: There is no "adjudication" in the sense of multiple human readers independently evaluating data for consensus, as would be done for an AI/software device. Performance is determined by objective measurements against predefined engineering specifications and biological safety limits.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No: This type of study is relevant for AI/software devices that assist human interpretation of medical data. It is not applicable to a physical catheter.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable: As stated, this is a physical medical device, not an algorithm.

7. The type of ground truth used

• Physical/Chemical Standards and Measurements: For biocompatibility, ground truth is based on established biological responses (e.g., cell viability for cytotoxicity, skin reaction for irritation, blood parameters for hemolysis) as defined by ISO 10993 series standards. For bench testing, ground truth is based on engineering specifications and mechanical properties (e.g., measured burst pressure, inflation time, pull strength, visual inspection against defects).

8. The sample size for the training set

• Not Applicable: This is not an AI/software device that requires a training set. The device itself is manufactured, not "trained."

9. How the ground truth for the training set was established

• Not Applicable: No training set or ground truth in the context of machine learning. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory standards for medical devices.

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EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.

EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.

This document describes the regulatory submission for the EMBOGUARD™ Balloon Guide Catheter (K212340). As such, the "acceptance criteria" and "device performance" refer to the results of bench and animal testing demonstrating substantial equivalence to a predicate device, rather than performance metrics for an AI algorithm. Therefore, many of the requested fields are not applicable in this context.

Here's a breakdown of the provided information, addressing your points where relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details numerous performance tests to demonstrate substantial equivalence to a predicate device. The general acceptance criterion for all of these tests is "Pass," meaning the device met the pre-determined specifications or demonstrated comparable performance to the predicate. The reported device performance for all listed tests is "Pass," indicating that all samples met the pre-determined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Bench Testing: The specific sample sizes for each bench test are not explicitly stated in the document. However, the results consistently state "All samples met the pre-determined acceptance criteria," implying that a sufficient number of samples were tested to gain confidence in the results according to the referenced standards. The data provenance is from internal testing conducted by Neuravi Ltd.
• Animal Studies: The document mentions "Acute animal study has been performed." The specific number of animals is not provided. The model used was a swine model. This is prospective data from animal testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. The device is a medical catheter, and its performance is evaluated through physical and biological testing, not by expert interpretation of images or other data that would require "ground truth" to be established by experts in the context of an AI study.

4. Adjudication Method for the Test Set

This information is not applicable. The device is a medical catheter, and its performance is evaluated through physical and biological testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted. This device is a physical medical device, not an AI algorithm requiring human reader performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through adherence to recognized international standards, internal specifications, and comparison to a predicate device. For example:

• Biocompatibility: Based on established biological response criteria defined in ISO 10993 series standards (e.g., non-cytotoxic, non-sensitizing, non-pyrogenic).
• Bench Testing: Based on pre-determined product performance specifications derived from relevant ISO standards (e.g., ISO 10555, ISO 11070) and FDA guidance documents.
• Animal Studies: Based on evaluation of usability, effectiveness, safety (histological evaluation), and comparison to the predicate device in a swine model.

There is no "expert consensus," "pathology," or "outcomes data" in the sense of a medical diagnostic ground truth for an AI algorithm.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. The device is a physical medical device, not an AI algorithm.

Summary for this specific device:

The K212340 submission for the EMBOGUARD™ Balloon Guide Catheter focuses on demonstrating substantial equivalence to an existing predicate device (8F FlowGate Balloon Guide Catheter, K153729) through extensive non-clinical testing.

• Acceptance Criteria: For all tests, the acceptance criteria were pre-determined specifications, often derived from international standards (e.g., ISO 10993, ISO 10555, ISO 11070, ISO 80369) and FDA guidance documents. For comparison studies, the criterion was similarity or equivalence to the predicate device.
• Device Performance: The device "Passed" all listed biocompatibility, sterilization/shelf-life, and bench tests, indicating it met the pre-determined acceptance criteria for each.
• Study Types: The studies included:
  • Biocompatibility Testing: Covering cytotoxicity, sensitization, intracutaneous irritation, systemic toxicity, hemocompatibility (hemolysis, complement activation, thrombogenicity), and genotoxicity.
  • Sterilization and Shelf Life Studies: Validation of EtO sterilization and 1-year shelf life.
  • Bench Testing: A comprehensive suite of physical and mechanical tests covering visual inspection, dimensions, torque, tensile strength, flexibility, kink resistance, lubricity, coating, particulates, radiopacity, simulated use (including clot retrieval), user evaluation, compatibility with ancillary devices, lumen integrity, and balloon performance. All these were direct physical tests of the device.
  • Animal Studies: An acute animal study in a swine model to assess usability, effectiveness, safety, and histological response compared to the predicate device.
• No clinical studies were performed.
• The document does not detail any AI component, and thus questions related to AI-specific metrics (sample sizes for training/test sets, expert ground truth, MRMC studies) are not relevant to this submission. The "ground truth" here refers to the validated physical and biological properties of the device as measured against established scientific and regulatory standards.

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